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https://ah.lib.nccu.edu.tw/handle/140.119/117183
題名: | Analysis of the Proposed TPP-Related Patent Linkage System in Taiwan | 作者: | 陳秉訓 Chen, Ping-Hsun |
貢獻者: | 科管智財所 | 日期: | Jul-2017 | 上傳時間: | 17-May-2018 | 摘要: | The Trans-Pacific Partnership (“TPP”) Agreement mandates member states to implement a patent linkage system vested in Article 18.53. To successfully join the TPP Agreement, Taiwan has begun the legislation of a patent linkage system by proposing an amendment for the Pharmaceutical Affairs Act. Article 18.53 requires a member either to adopt a notification mechanism under Paragraph 1 or to stay the issuance of marketing approval under Paragraph 2. But, Taiwan’s proposal includes both measures. Taiwan’ patent linkage system allows a pioneer drug company to register patents claiming (a) a material; (b) a combination or formula; or (c) pharmaceutical use. The scope of patentees who may benefit from the mechanism is larger than what is required. In addition, the system requires a generic drug company to notify the patentee at the time of filing the drug application if the generic drug company asserts invalidity or non-infringement which the generic drug company must prove. Furthermore, the health authority is allowed to stay the issuance of a generic drug permit while the patentee is suing the generic drug company in the court. | 關聯: | Journal of Law and Health, Vol.30, No.1, pp.55-79 | 資料類型: | article |
Appears in Collections: | 期刊論文 |
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T415741.pdf | 633.57 kB | Adobe PDF2 | View/Open |
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